Inspection Readiness: Supporting a top 20 pharma company in ensuring regulatory compliance with highest standards

Together for better health

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Therapeutic area : Multiple therapies Product type : Drugs

Geography : US, EU Product lifecycle stage : For all products through the product lifecycle

The client is a global pharma company with a global presence in 40 countries and has experience across major therapeutic segments of cardiovascular (CV), central nervous system (CNS), gastrointestinal system, diabetology, pediatrics, and complex areas such as oncology with an advanced research and development (R&D) capability. It also had several innovative products addressing the needs of growing therapeutic areas such as gastroenterology, cardiology, diabetology, psychiatry, neurology, anti-bacterial, anti-infectives, and pain management.

About the client

Business challenge

Overview

Pharmaceutical, medical device, and biotech companies are constantly required to be ready for the Food and Drug Administration (FDA) and European Union (EU) Authority inspections. While some inspections are usually pre-determined (e.g., Medicines and Healthcare products Regulatory Agency [MHRA]), others are mostly unannounced (e.g., FDA). It is, therefore, critical to have a team and a system in place to ensure that all inspections are carried out effectively with minimum additional preparation. The FDA's safety-related inspections grew 66% during the period from 2011 to 2016. Further, the FDA is planning to double their foreign inspections annually over the next 5 years, as mandated by the US Food Safety and Drug Modernization Act, 2011. Pharma companies continually strive to improve processes and systems through a well-implemented quality management system (QMS) for demonstrating regulatory compliance. A trained and experienced quality assurance (QA) team with domain expertise in Good Clinical Practice and Good Pharmacovigilance Practice (GCP/GVP) and an effective QMS is, therefore, a mandate for any pharma company. A QMS ensures that the company is keeping up with changes controls, deviations, corrective actions preventive actions (CAPAs), and any outstanding action items from previous audits. The company must ensure that organizational charts, metrics, and training requirements are in place.

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The pharma company was notied of a pharmacovigilance inspection by FDA Inspectors 3 days prior to their arrival. There were several challenges such as

limited time for inspection preparedness,

lack of clarity on inspection readiness and know-how, and

limited resources at the inspection site, cluttered documentation, and segregated data sources.

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Solution

The pharma company approached the APCER QA team. The team, based on its rich experience for hosting FDA and MHRA Inspections, acted swiftly to

gather all the preliminary information and immediately conduct a gap analysis of existing systems within 3 days and identify key areas for inspection preparation;

ensure the inspection preparedness of the personnel at the client site byconducting trainings,conducting mock interviews,conducting war room readiness workshop,documenting request management trackers,advising how to attend interviews with the inspector, particularly in difficult situations throughout the inspection, andcovering all information technology (IT) and administrative aspects; and

communicate a clear plan for successful inspection preparedness that was documented for the team to provide continuous inspection support.

Together for better health

Outcome

The pharma company successfully hosted the FDA inspection with no form 483s (Notice of Inspectional Observations).

The site personnel were well appreciated by the inspectors for apt responses and for providing the required documents in a timely manner.

The inspected processes demonstrated high standards of regulatory compliance.

Together for better healthAPCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory and technology resources to ensure that patients receive the safest, most effective therapies possible.

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Learn more at www.apcerls.com/services/safetyor contact us at one of our global offices:America : (+1) 609 455 1600 • Europe : (+44) 208 326 3220 • Asia : (+91) 11 4650 0802

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Quality Assurance CapabilitiesWell-trained and experienced QA team with domain experience of more than 500+ GVP and GCP audits within the QA team.

Experience in conducting audits in multiple countries, including USA, EU, and Asia, in various therapeutic areas on over a wide range of products, including biologics.

Hands-on experience in end-to-end QMS services, e.g., CAPA, deviations, and standard operation procedure (SOP) management by dedicated resources.

Participation of and support to over 50 global PV inspections of clients since 2017.

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